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Do Negative Trials Count More Than Successful Ones?

 
• By Sue Sutter

Fabre-Kramer, FDA dispute over efficacy of the antidepressant gepirone heads to Psychopharmacologic Drugs Advisory Committee.

An FDA advisory committee's evaluation of Fabre-Kramer Pharmaceuticals Inc.'s investigational antidepressant gepirone may turn on a question of interest to the broader pharmaceutical industry: How should the requirement for substantial evidence of effectiveness be interpreted when there are multiple negative or failed trials along with positive ones?

The Psychopharmacologic Drugs Advisory Committee will meet Dec. 1 to discuss the efficacy and safety data for gepirone hydrochloride extended-release...

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BIO Notebook: Policy Uncertainty Constraining Dealmaking

 
• By Mandy Jackson and Joseph Haas

Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 
• By Sarah Karlin-Smith

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By Sue Sutter

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.